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Monoclonal Antibodies
Dose 1 for Thermal Burn Pain
Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.
Eligible Conditions
- Thermal Burn Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in procedural pain intensity
Secondary outcome measures
Additional quality of life assessments
Cumulative analgesic usage
Weekly Patient-rated Global Impression of Change
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment1 Intervention
R475
Group II: Dose 1Experimental Treatment1 Intervention
R475
Group III: Dose 3Placebo Group1 Intervention
Placebo to match R475 dose
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
626 Previous Clinical Trials
381,825 Total Patients Enrolled
SanofiIndustry Sponsor
2,170 Previous Clinical Trials
3,516,422 Total Patients Enrolled
Paul Tiseo, PhDStudy DirectorRegeneron Pharmaceuticals
3 Previous Clinical Trials
286 Total Patients Enrolled
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